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Managing Medical Devices Within a Regulatory Framework


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This much-needed guide helps engineers ensure proper maintenance of medical equipment for FDA, CE, and HIPAA compliance and safety, anticipate equipment problems and legal issues, and utilize equipment funding wisely

Table of Contents

Foreword, Larry Fenningkoh 1. Reframing Product Life Cycle for Medical Devices, Beth Fiedler 2. Overview of Medical Device Clinical Trials, Beth Fiedler, Michael Ferguson 3. Review Regulatory Guidelines by Device Classification Type, Beth Fiedler 4. Manufacturing/Distribution, Beth Fiedler 5. Overview and Application in Clinical Engineering, Beth Fiedler 6. Roles of Biocompatibility, Beth Fiedler 7. Risk Management, Beth Fiedler, Abdullah Farid 8. Sterility and Reusability, Beth Fiedler 9. EU National Differences and Potential Impact on CE Marking, Beth Fiedler 10. Understanding the Transitioning Regulatory EU Market, Beth Fiedler 11. Evaluating new medical equipment purchases, Beth Fiedler 12. Evaluating Reimbursement Strategies in the US, Beth Fiedler , Jeremiah Greathouse 13. Healthcare Facility Users Legal Responsibilities and Risks, Marc Sanchez 14. Clinical and Biomedical Engineering Evidence Strategy, Beth Fiedler 15. Device Failure Tracking and Response to Manufacturing Recalls, Beth Fiedler 16. Health Economics and Outcomes Research and Evidence Strategies, Michael Ferguson 17. The Future of Health Technology Management, Beth Fiedler 18. Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance, Beth Fiedler 19. Managing Smartphone and Tablet Applications, Beth Fiedler

About the Author

Beth Ann earned her doctorate in Public Affairs at the University of Central Florida. The author of books on innovative approaches to healthcare quality; Dr. Fiedler has also successfully completed quality-award winning management projects for the private sector and the US military. Her research includes policy analysis focused on healthcare quality and business development presented to U.S. Congressional representatives, medical, technology and business audiences in the US and abroad. She has published in several peer-reviewed journals, was named a Founder's Fellow by the American Society for Public Administration in 2014 and was featured by the US National Center for Policy Analysis for "Ideas Changing the World" on Health Issues.

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